Study on the Accuracy of 68Ga-FAPI-46 and Fludeoxyglucose (18F) PET/CT Scans for Staging and Restaging in Patients with Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying Ovarian Cancer, a type of cancer that begins in the ovaries. The study will use two different imaging methods to help understand the disease better. The first method involves a special injection called 68Ga-FAPI-46, which is a solution used in a type of scan called PET/CT. The second method uses another injection called Fluor-18-FDG, which is also used in PET/CT scans. These scans help doctors see how the cancer is behaving inside the body.

The purpose of the study is to compare how well these two imaging methods work in detecting ovarian cancer. Participants will undergo both types of scans at different stages of their treatment. The study will look at how these scans can help in the initial diagnosis and in checking the cancer’s status after treatment. This will help doctors understand if the new method, using 68Ga-FAPI-46, provides better information than the traditional method with Fluor-18-FDG.

Throughout the study, the safety of the 68Ga-FAPI-46 injection will be monitored. Participants will have their heart rate and blood pressure checked before and after the injection to ensure there are no adverse effects. The study aims to see if the new imaging method can improve how doctors manage and treat ovarian cancer, potentially leading to better outcomes for patients.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of ovarian cancer or a strong suspicion of it, based on medical data.

The assessment ensures that the patient is physically and mentally able to participate and can provide informed consent.

2 first imaging session

The first imaging session involves a FDG PET/CT scan. This scan uses a solution called Fluor-18-FDG, which is injected as an intravenous solution.

The purpose of this scan is to assess the cancer’s stage and to provide a baseline for comparison with future scans.

3 FAPI PET/CT scan

A FAPI PET/CT scan is performed using a solution called 68Ga-FAPI-46, administered as an intravenous infusion.

This scan aims to evaluate the diagnostic accuracy of FAPI PET/CT compared to the FDG PET/CT.

4 treatment phase

During the treatment phase, patients may undergo chemotherapy as part of their standard care. This phase is not directly part of the trial but is relevant for subsequent imaging.

5 restaging imaging session

After chemotherapy, a second set of imaging sessions is conducted. This includes both FDG PET/CT and FAPI PET/CT scans.

These scans are used to restage the cancer and assess any changes in the tumor and surrounding areas.

6 data analysis and follow-up

The results from the imaging sessions are analyzed to compare the effectiveness of the FAPI PET/CT against the FDG PET/CT.

Follow-up assessments may be conducted to monitor any changes in health status and to evaluate the safety of the 68Ga-FAPI-46 injection.

Who Can Join the Study?

Must have a new diagnosis of ovarian cancer confirmed by a biopsy (a small sample of tissue taken to check for cancer) or be highly suspected to have ovarian cancer based on all information reviewed by a team of specialists in women’s cancers.
Must be considered suitable for surgery, with or without prior chemotherapy (treatment with drugs to kill cancer cells), as determined by the team of specialists.
Must be physically and mentally able to take part in the research study.
Must be 18 years or older and able to give consent to participate in the study.
Must be able to read and understand Danish.

Who Cannot Join the Study?

Patients who are not diagnosed with Ovarian Cancer cannot participate.
Only female patients are eligible, so male patients cannot participate.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

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Site Name	City	Country	Status
Aalborg University Hospital	Aalborg	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	20.10.2023

Trial locations

Investigated drugs:

68Ga-FAPI-46: This is a special imaging agent used in PET/CT scans to help doctors see certain types of cancer more clearly. It is injected into the body and helps highlight cancerous areas during the scan, making it easier to diagnose and understand the extent of ovarian cancer. This trial is looking at how well this imaging agent works compared to another one and how it might change the way doctors manage the treatment of ovarian cancer.

Investigated diseases:

Ovarian cancer

Ovarian Cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are part of the female reproductive system. It often goes undetected until it has spread within the pelvis and abdomen. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms can include abdominal bloating, pelvic pain, and changes in bowel habits. The disease can spread to nearby tissues and organs, and in advanced stages, it may affect distant parts of the body. The progression of ovarian cancer can vary, with some types growing slowly and others more rapidly. Understanding the specific type and stage of ovarian cancer is crucial for determining its progression.

Trial ID:

2023-505938-98-00

NCT ID:

NCT05903807

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Accuracy of 68Ga-FAPI-46 and Fludeoxyglucose (18F) PET/CT Scans for Staging and Restaging in Patients with Ovarian Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?